Date: 2017-01-05
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: Keystone Nano (USA - PA)
Product: ceramide nanoliposome
Action
mechanism: nanotechnology product. Ceramide is a bioactive lipid that has shown efficacy in multiple models of liver cancer, as well as in breast cancer, leukemia and pancreatic cancer. Evidence collected in a large number of research tests (in vitro and in vivo) has clearly demonstrated that ceramide nanoliposome kills cancer cells while leaving normal cells alone, providing treatment without undue toxicity.
Disease: solid tumors
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This study is a dose escalation study of ceramide nanoliposome in patients with advanced solid tumors.(NCT02834611)
Latest
news: * On January 5, 2017, Keystone Nano announced that the FDA has approved the company’s Investigational New Drug (IND) Application to assess ceramide nanoliposome in the treatment of solid tumors. The therapy will be tested in a Phase I clinical trial at three sites: the University of Maryland, the University of Virginia and the Medical University of South Carolina. The clinical trial will enable the company to establish a safe dose level, and begin gathering information about the efficacy of the product as a cancer therapy. The Phase I portion of the trial will recruit patients with solid tumors to establish dosing and safety. The Phase II component of the trial is expected to focus on liver cancer, which kills approximately 27,000 people in the United States and 700,000 worldwide each year. There is currently no effective therapy for this disease.
